Respiratory Tract Infections Clinical Trial
Official title:
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like Particles (VLP) Quadrivalent Influenza Vaccine in the Elderly Population
This is a multiple sites phase II trial, randomized, observer-blind, dose ranging,
placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single
intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine
administered in elderly subjects (50 years old and more).
A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75
subjects to receive one injection of either a non-adjuvanted low, medium or high dose level
of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined
with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer
+ 150 mM sodium chloride (NaCl) + 0.01% Tween 80)
This study will use cohort staggering (slow enrollment) for 3 non-adjuvanted dose levels
(low, medium, high dose level of VLP per strain), 2 adjuvanted dose levels (low or high dose
level of VLP per strain) and a placebo-controlled group divided in 3 cohorts:
- Cohort 1: Approximately one hundred and thirty-eight (138) subjects will be randomized
and dosed as follows: seventy-five (75) subjects with the lowest non-adjuvanted dose of
the quadrivalent VLP vaccine, nineteen (19) subjects with the medium non-adjuvanted dose
of the quadrivalent VLP vaccine, nineteen (19) subjects with the lowest adjuvanted dose
of the quadrivalent VLP vaccine and twenty-five (25) subjects with a placebo. The 7-day
safety data after the immunization will be collected by the clinical staff and will be
reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB consisting of the PIs,
the Sponsor's Medical Officer and 3 external medical advisors (voting members); the
members will determine if the clinical sites are allowed to continue with the
immunization of the second cohort.
- Cohort 2: Approximately one hundred and seventy-five (175) subjects will be randomized
and dosed as follows: fifty-six (56) subjects with the medium non-adjuvanted dose
quadrivalent VLP vaccine, fifty-six (56) subjects with the lowest adjuvanted dose
quadrivalent VLP vaccine, nineteen (19) subjects with the highest adjuvanted dose
quadrivalent VLP vaccine, nineteen (19) subjects with the highest non-adjuvanted dose
quadrivalent VLP vaccine and twenty-five (25) subjects with a placebo. The 7-day safety
data after the immunization will be collected by the clinical staff and reviewed by the
DSMB prior to allowing immunization of the third cohort.
- Cohort 3: Approximately one hundred and thirty-seven (137) subjects will be randomized
and dosed as follows: fifty-six (56) subjects with the highest adjuvanted dose,
fifty-six (56) subjects with the highest non-adjuvanted dose and twenty-five (25)
subjects with a placebo.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Terminated |
NCT04583280 -
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
|
Phase 3 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
Completed |
NCT02561871 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
|
Phase 1 | |
Terminated |
NCT02032056 -
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
|
N/A | |
Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
Completed |
NCT01419262 -
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
|
Phase 3 | |
Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
Active, not recruiting |
NCT01107223 -
Long Term Effect of General Practitioner Education on Antibiotic Prescribing
|
N/A | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Completed |
NCT04144491 -
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
|
N/A | |
Completed |
NCT05318235 -
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
|
||
Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
Completed |
NCT04525040 -
ProbioKid as Prevention Among Kids With Frequent URTI
|
N/A | |
Completed |
NCT05535777 -
Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)
|
N/A | |
Not yet recruiting |
NCT05914324 -
Outpatient Pediatric Pulse Oximeters in Africa
|
N/A |